Teemu J. Murtola , Tuukka Hakkarainen , Mari Lahelma , Paula Pennanen , Riikka-Leena Leskelä , Mika Pietilä , Petteri Hervonen , Okko-Sakari Kääriäinen , Heikki Minn , Timo K. Nykopp , Hanna Ronkainen , Otto Ettala , Antti Rannikko
{"title":"Healthcare Resource Use and Costs of Localized Prostate Cancer Patients in Finland","authors":"Teemu J. Murtola , Tuukka Hakkarainen , Mari Lahelma , Paula Pennanen , Riikka-Leena Leskelä , Mika Pietilä , Petteri Hervonen , Okko-Sakari Kääriäinen , Heikki Minn , Timo K. Nykopp , Hanna Ronkainen , Otto Ettala , Antti Rannikko","doi":"10.1016/j.clgc.2025.102427","DOIUrl":"10.1016/j.clgc.2025.102427","url":null,"abstract":"<div><h3>Background</h3><div>Prostate cancer is the most prevalent cancer among men in Finland, causing significant healthcare costs. Understanding the economic burden of various treatment pathways is vital for optimizing healthcare strategies. This study aimed at estimating healthcare resource utilization and associated costs for patients with localized prostate cancer (LPC) and locally advanced prostate cancer (LAPC) based on initial treatment decisions in Finland.</div></div><div><h3>Patients and Methods</h3><div>A retrospective, noninterventional study was conducted using pseudonymized patient-level data from the 5 University Hospitals and the Social Insurance Institution of Finland. The cohort included 16,212 adults diagnosed with localized prostate cancer (LPC) or locally advanced prostate cancer (LAPC) between 1 July 2010 and 30 June 2021. Patients were categorized into 4 groups: no immediate treatment (NIT), radiotherapy only (RT), radiotherapy combined with androgen deprivation therapy (RT+ADT), and radical prostatectomy (RP). Healthcare resource utilization and costs were analyzed on a per-patient-year basis, considering inpatient admissions, outpatient visits, emergency department visits, and outpatient medication costs.</div></div><div><h3>Results</h3><div>The first-year costs were highest for RP (€11,766) and RT+ADT (€10,421), reflecting intensive treatment, followed by RT only (€9,014) and no immediate treatment (NIT) (€4,129). Over time, costs decreased for RP and RT+ADT groups. Emergence of metastatic disease significantly increased costs, particularly due to outpatient medication. Costs began rising 1-2 years before metastasis, indicating early health deterioration.</div></div><div><h3>Conclusion</h3><div>This study highlights significant cost variations across different treatment pathways for prostate cancer in Finland and underscores the economic impact of metastatic disease. Early detection and effective management are essential for cost containment.</div></div>","PeriodicalId":10380,"journal":{"name":"Clinical genitourinary cancer","volume":"23 6","pages":"Article 102427"},"PeriodicalIF":2.7,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145180820","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Impact of Impaired Renal Function on the Efficacy and Safety of Enfortumab Vedotin Monotherapy in a Multicenter Real-World Cohort of Patients With Metastatic Urothelial Cancer: YUSHIMA Study","authors":"Hiroshi Fukushima , Yuki Nakamura , Hajime Tanaka , Noboru Numao , Atsushi Yoshinaga , Naoko Kawamura , Kenji Tanabe , Keita Izumi , Takanobu Yamamoto , Sho Uehara , Yuya Maezawa , Takahiko Soma , Ryoji Takazawa , Saori Araki , Soichiro Yoshida , Yasuhisa Fujii","doi":"10.1016/j.clgc.2025.102426","DOIUrl":"10.1016/j.clgc.2025.102426","url":null,"abstract":"<div><h3>Introduction</h3><div>Enfortumab vedotin (EV) has become a standard of care for patients with metastatic urothelial cancer (mUC). However, the impact of impaired renal function on its efficacy and safety remains unclear, especially in patients with severe renal impairment who are considered unfit for platinum-based chemotherapy.</div></div><div><h3>Patients and Methods</h3><div>This multicenter retrospective study included 115 patients with mUC who were treated with EV monotherapy after progression on platinum-based chemotherapy and immune checkpoint inhibitors. Patients were stratified into 3 groups based on pretreatment estimated glomerular filtration rate (eGFR, mL/min/1.73 m<sup>2</sup>): Preserved (eGFR ≥ 45, <em>n</em> = 65), Moderately Impaired (30 ≤ eGFR < 45, <em>n</em> = 36), and Severely Impaired (eGFR < 30, <em>n</em> = 14). Objective response rate (ORR), progression-free survival (PFS), overall survival (OS), and treatment-related adverse events (TRAEs) were compared among the 3 groups.</div></div><div><h3>Results</h3><div>The median follow-up time following after the initiation of EV treatment was 7.2 months. Although relative dose intensity (RDI) was lower in the Severely Impaired group, ORR (<em>P</em> = .62), PFS (<em>P</em> = .33), and OS (<em>P</em> = .81) were not significantly different among the 3 groups. There was no significant difference in the incidence of any grade TRAEs among the 3 groups (<em>P</em> = .22). For grade ≥ 3 TRAEs, its incidence was significantly different overall (<em>P</em> = .040), but no pairwise differences were found after Bonferroni correction. Among patients with RDI ≥ 80%, impaired renal function was not significantly associated with the incidence of TRAEs.</div></div><div><h3>Conclusions</h3><div>EV monotherapy demonstrated comparable efficacy and safety regardless of renal function in patients with mUC. Our findings suggest that impaired renal function alone may not warrant avoiding EV monotherapy or routinely reducing its dose. Moreover, EV monotherapy can be effective and well-tolerated even in patients with eGFR < 30 who are considered unfit for platinum-based chemotherapy.</div></div>","PeriodicalId":10380,"journal":{"name":"Clinical genitourinary cancer","volume":"23 6","pages":"Article 102426"},"PeriodicalIF":2.7,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145115467","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Titrating Cabozantinib in Metastatic Renal Cell Carcinoma Patients Using Goldilocks Principle: A Real-World Evidence Study","authors":"Malou Aarønæs Thybo , Johanne Ahrenfeldt , Iben Lyskjær , Niels Fristrup","doi":"10.1016/j.clgc.2025.102419","DOIUrl":"10.1016/j.clgc.2025.102419","url":null,"abstract":"<div><h3>Introduction</h3><div>The incidence of renal cell carcinoma (RCC) continues to rise worldwide, and this malignancy has demonstrated substantial sensitivity to both immunotherapies and targeted agents, particularly tyrosine kinase inhibitors (TKIs). Cabozantinib, a commonly utilized TKI, has shown promising efficacy across multiple clinical trials. This study aims to evaluate the real-world effectiveness of individualized cabozantinib dosing as a later-line treatment in patients with metastatic RCC (mRCC).</div></div><div><h3>Patients and methods</h3><div>Patients with mRCC treated at the Department of Oncology, Aarhus University Hospital, Denmark, were identified to estimate the median progression free survival (mPFS) and median overall survival (mOS) from treatment initiation. Best radiological response was evaluated using RECIST 1.1. Multivariable cox regression analyses were performed, including covariates such as brain metastasis, first-line treatment, line of treatment, ECOG Performance Status, IMDC risk group, nephrectomy status, and toxicity.</div></div><div><h3>Results</h3><div>A total of 179 patients were included, of which 139 patients received second-line (2L) treatment, and 40 patients received third+-line (3+L) treatment. We found a mPFS of 11.2 months for 2L treatment and 11.6 months for 3+L treatment. The mOS was 15.6 months for the 2L group and 17.1 months for the 3+L group. The mPFS and mOS in the IMDC favourable risk group were 28.5 and 52.1 months, respectively. No significant differences in mPFS or mOS were observed based on prior 1L treatment or the presence of brain metastases. The mOS and mPFS found in this study are comparable to, and in some cases exceed, those reported in other real-world cohorts. Interestingly, we found treatment-related toxicity to correlate significantly with an increased survival (mOS 66.8 vs. 32.8 months, <em>P</em> = .016) (mPFS 14,7 vs. 8,5 months, P = .013).</div></div><div><h3>Conclusion</h3><div>This study reinforces the existing data on effectiveness of cabozantinib as a later-line treatment for mRCC in real-world settings. We report 40 mg as the preferred landing zone. Furthermore we identify patients needing dose reductions due to toxicity as a subgroup carrying a significantly better prognosis. The results emphasize the importance of individual dosage for optimizing treatment outcomes and points out treatment-related toxicity as a surrogate marker for sufficient serum concentration of the active substance.</div></div>","PeriodicalId":10380,"journal":{"name":"Clinical genitourinary cancer","volume":"23 6","pages":"Article 102419"},"PeriodicalIF":2.7,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145096761","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"The Clinicopathological Characteristics and Survival Outcomes of Primary Squamous Cell Carcinoma of the Kidney: A SEER-Based Population Analysis","authors":"Cagatay Ozsoy, Erhan Ates","doi":"10.1016/j.clgc.2025.102455","DOIUrl":"10.1016/j.clgc.2025.102455","url":null,"abstract":"<div><h3>Introduction</h3><div>Primary squamous cell carcinoma (SCC) of the kidney is an exceptionally rare malignancy, current knowledge being limited to isolated case reports and small case series. This study represents the first population-based analysis of SCC of the kidney using data from the Surveillance, Epidemiology, and End Results (SEER) database.</div></div><div><h3>Patients and Methods</h3><div>This retrospective cohort study was conducted using the SEER Research Data (2000-2022). Patients aged ≥ 15 years with histologically confirmed primary renal SCC and tumor site C64.9 (kidney) were included. Patients were categorized into metastatic and non-metastatic subgroups. Survival outcomes in the overall cohort were estimated using the Aalen–Johansen method to generate cumulative incidence functions, while Gray’s test was applied for subgroup comparisons. Prognostic factors associated with cancer-specific mortality (CSM) in the overall cohort and the metastatic subgroup were evaluated using the Fine–Gray proportional subdistribution hazards model.</div></div><div><h3>Results</h3><div>The 2-year CSM rate among the 114 patients was 83.7%. The majority of patients (78.9%) were aged ≥ 60 years. In the overall cohort, right-sided tumor location (<em>P</em> = .026) and bone metastasis at diagnosis (<em>P</em> < .001) were significantly associated with an increased risk of CSM, while unmarried status (<em>P</em> = .090), lack of surgical treatment (<em>P</em> = .054), and receipt of radiotherapy (<em>P</em> = .050) exhibited borderline associations with an increased risk. At multivariate analysis, right-sided tumor location and radiotherapy were independently associated with poorer survival, while surgical treatment emerged as an independent predictor of improved survival in the metastatic group.</div></div><div><h3>Conclusions</h3><div>Primary SCC of the kidney is a rare and aggressive malignancy, typically diagnosed at advanced stages and associated with poor outcomes. Unmarried status, right-sided tumor location, bone metastasis at diagnosis, lack of surgical treatment, and receipt of radiotherapy were associated with an increased risk of CSM. Further multicenter studies with detailed clinical data are now needed to guide evidence-based management of this uncommon disease.</div></div>","PeriodicalId":10380,"journal":{"name":"Clinical genitourinary cancer","volume":"23 6","pages":"Article 102455"},"PeriodicalIF":2.7,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145460948","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Prateek Jain , Syed Arsalan Ahmed Naqvi , Nikita Tripathi , Japneet K Oberoi , Muhammad Abdullah Humayun , Yousef Zakharia , Jacob J Orme , Adam Kase , Dan S Childs , Ruqin Chen , Irbaz B Riaz , Parminder Singh
{"title":"Real-World Outcomes of Enfortumab Vedotin and Pembrolizumab in Advanced Urothelial Carcinoma: A Multicenter Retrospective Analysis","authors":"Prateek Jain , Syed Arsalan Ahmed Naqvi , Nikita Tripathi , Japneet K Oberoi , Muhammad Abdullah Humayun , Yousef Zakharia , Jacob J Orme , Adam Kase , Dan S Childs , Ruqin Chen , Irbaz B Riaz , Parminder Singh","doi":"10.1016/j.clgc.2025.102453","DOIUrl":"10.1016/j.clgc.2025.102453","url":null,"abstract":"<div><h3>Introduction</h3><div>Enfortumab vedotin plus pembrolizumab has emerged as a new standard of care for previously untreated patients with advanced urothelial carcinoma following the EV-302 trial. However, data on its efficacy and safety in routine clinical practice remain limited. Herein, we evaluated real-world clinical outcomes for patients with advanced urothelial carcinoma receiving the combination as first-line or subsequent-line therapy.</div></div><div><h3>Patients and Methods</h3><div>This retrospective cohort study included adults (≥18 years) with histologically confirmed bladder or upper tract urothelial carcinoma (other histologic type variants were also included), who initiated treatment with enfortumab vedotin-pembrolizumab therapy between May 2020 and December 2024 at the Mayo Clinic. Patients initiating therapy after December 2024 or with incomplete data were excluded. Patients were stratified by line of therapy: Cohort A included patients who received enfortumab vedotin-pembrolizumab as first-line therapy, and Cohort B included patients who received it as subsequent-line therapy. The primary endpoint was to estimate median progression-free survival in cohort A and cohort B.</div></div><div><h3>Results</h3><div>A total of 183 patients with advanced urothelial carcinoma treated with the enfortumab vedotin-pembrolizumab combination were included. The median age at treatment initiation was 71.9 years (IQR, 64.7-77.4). Most patients were male (71.0%) and white (90.7%). The median progression-free survival was 12.9 months (95% CI, 9.5-NE) in Cohort A and 9.3 months (95% CI, 6.3-NE) in Cohort B. This difference was not statistically significant (HR, 1.30; 95% CI, 0.83-2.04; <em>P</em> = .246). Treatment-related adverse events of any grade were reported in 93.4% of patients, with 30.6% experiencing Grade ≥3 AEs.</div></div><div><h3>Conclusion</h3><div>In this real-world cohort, enfortumab vedotin-pembrolizumab combination demonstrated meaningful clinical activity and manageable toxicity in both first-line and subsequent-line settings, consistent with results from the EV-302 trial.</div></div>","PeriodicalId":10380,"journal":{"name":"Clinical genitourinary cancer","volume":"23 6","pages":"Article 102453"},"PeriodicalIF":2.7,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145433037","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Daniele Robesti , Filippo Micheli , Shesh N. Rai , Giuseppe Fallara , Andrea Gallina , Francesco Montorsi , Alberto Briganti , Nicola Fossati , Petros Grivas , Antoine G. van der Heijden , Guillaume Ploussard , Bernard Malavaud , Alberto Martini
{"title":"Addressing Uneven Treatment Discontinuation Rate in the Chemotherapy Arm of the EV-302 Phase 3 Randomized Clinical Trial: Implications for Outcome Interpretation","authors":"Daniele Robesti , Filippo Micheli , Shesh N. Rai , Giuseppe Fallara , Andrea Gallina , Francesco Montorsi , Alberto Briganti , Nicola Fossati , Petros Grivas , Antoine G. van der Heijden , Guillaume Ploussard , Bernard Malavaud , Alberto Martini","doi":"10.1016/j.clgc.2025.102423","DOIUrl":"10.1016/j.clgc.2025.102423","url":null,"abstract":"<div><h3>Introduction</h3><div>The EV-302 trial demonstrated a very significant overall survival (OS) benefit for Enfortumab Vedotin plus Pembrolizumab (EVP) relative to standard chemotherapy (CHT) for patients with metastatic urothelial carcinoma. However, questions have been raised regarding the high rate of treatment discontinuation in the CHT arm for reasons unrelated to adverse events or progression (33% vs. 10% with EVP, <em>P</em> < .01), potentially resulting in loss of unaccounted information, or informative censoring, and affecting survival results interpretation.</div></div><div><h3>Materials and Methods</h3><div>We performed a multistep analysis to assess the impact of differential dropout on trial outcomes. First, Kaplan–Meier (KM) curves were reconstructed from published data to estimate time-to-event outcomes. Second, a reverse KM analysis was conducted to evaluate censoring patterns in the overall population and key subgroups (PD-L1 expression; cisplatin eligibility). Third, simulation models were employed to test whether informative censoring could negatively impact survival benefit by EVP. Finally, we compared the CHT arm of EV-302 to those of other contemporary RCTs through reconstructed survival analyses and risk-of-bias assessments.</div></div><div><h3>Results</h3><div>Overall, no significant imbalance in censoring between the treatment arms of EV-302 was found on reverse KM analysis when assessing OS (<em>P</em> = .73); however, a significant difference was noted for progression-free survival (PFS) (<em>P</em> = .002). Simulation analysis revealed that even under extreme assumptions of informative censoring, the OS benefit of EVP remained statistically significant. Comparison with historical RCTs confirmed that the CHT outcomes in EV-302 were not anomalously poor. Risk of bias was low overall, although deviations from intervention and outcome measurement were flagged for EV-302.</div></div><div><h3>Conclusions</h3><div>Despite the high discontinuation rate in the CHT arm, OS benefit with EVP remains robust. These findings support the reliability of EV-302 results and mitigate concerns about informative censoring, thus encouraging the use of EVP in clinical practice.</div></div>","PeriodicalId":10380,"journal":{"name":"Clinical genitourinary cancer","volume":"23 6","pages":"Article 102423"},"PeriodicalIF":2.7,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145228600","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Jorge Augusto Alcacio-Mendoza, Horst Emanuel Lagos-Beitz, Petra Betsabé Carreño-Hinojosa, Yoztinn Bernal-Benitez, Guillermo H Martínez-Delgado, Ricardo A Castillejos-Molina, Francisco Rodriguez-Covarrubias
{"title":"Stage Migration in Surgically Treated Renal Cell Carcinoma in México: A 44-Year Analysis of Survival Outcomes and Stage-Specific Prognostic Factors","authors":"Jorge Augusto Alcacio-Mendoza, Horst Emanuel Lagos-Beitz, Petra Betsabé Carreño-Hinojosa, Yoztinn Bernal-Benitez, Guillermo H Martínez-Delgado, Ricardo A Castillejos-Molina, Francisco Rodriguez-Covarrubias","doi":"10.1016/j.clgc.2025.102416","DOIUrl":"10.1016/j.clgc.2025.102416","url":null,"abstract":"<div><h3>Background and objective</h3><div>Renal cancer (RC) diagnosis has shifted toward earlier stages globally. However, this phenomenon and its impact on outcomes have not been characterized in Mexico. We aimed to analyze temporal trends in RC stage at diagnosis and assess their impact on survival rates.</div></div><div><h3>Methods</h3><div>We retrospectively analyzed 807 patients surgically treated (1980-2024), categorized by diagnosis decade. Median follow-up was 29.0 months (range: 0.0-298.4) calculated using reverse Kaplan-Meier method. We developed the Stage Migration Index (SMI) using weighted averages of stage proportions to quantify migration magnitude. Survival was analyzed using Kaplan-Meier curves and multilevel analysis evaluated hierarchical effects of decade and stage on outcomes.</div></div><div><h3>Results</h3><div>Stage I cases increased from 29.9% to 52.9%, while Stage III decreased from 31.9% to 13.4% (<em>P</em> < .001) and Stage IV from 10.6% to 6.7% (<em>P</em> = .317, nonsignificant). The SMI increased from 2.766 to 3.261, reflecting significant shift toward earlier stages (<em>P</em> < .001). Incidental detection increased from 44.7% (95% CI, 31.4%-58.8%) to 58.2% (95% CI, 49.7%-66.2%) (<em>P</em> < .001). Five-year survival improved from 85.7% (1980-1989) to 96.3% (2020-2024) (<em>P</em> < .001), though the 2020 to 2024 cohort had limited follow-up (median 1.4 months). Multilevel analysis revealed decade effects varied by stage, with greatest improvement for Stage IV patients (β = −0.542, <em>P</em> = .013). Among deceased patients, survival time increased from 5.2 to 50.2 months between 1980-1989 and 2010-2019 (<em>P</em> < .001). Limitations include retrospective single-center design, surgical cohort selection bias, and 12.5% missing survival data.</div></div><div><h3>Conclusions</h3><div>RC has undergone significant stage migration in Mexico over 4 decades. While this shift contributes to improved outcomes, our analysis demonstrates substantial survival gains across all stages, particularly in advanced disease, suggesting improvements in comprehensive RC management beyond earlier detection alone.</div></div>","PeriodicalId":10380,"journal":{"name":"Clinical genitourinary cancer","volume":"23 6","pages":"Article 102416"},"PeriodicalIF":2.7,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145061229","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Daniel M. Geynisman , William S. John , Taavy A. Miller , Parisa Asgarisabet , Angelica Falkenstein , Kristin M. Zimmerman Savill , Xin Yin , Viviana del Tejo , Sarah B. Guttenplan , Lisa Rosenblatt
{"title":"Real-World Outcomes of Nivolumab Plus Ipilimumab Versus Pembrolizumab Plus Axitinib for First-Line Treatment of Advanced Renal Cell Carcinoma","authors":"Daniel M. Geynisman , William S. John , Taavy A. Miller , Parisa Asgarisabet , Angelica Falkenstein , Kristin M. Zimmerman Savill , Xin Yin , Viviana del Tejo , Sarah B. Guttenplan , Lisa Rosenblatt","doi":"10.1016/j.clgc.2025.102443","DOIUrl":"10.1016/j.clgc.2025.102443","url":null,"abstract":"<div><h3>Background</h3><div>In the absence of head-to-head trials, real-world (RW) outcomes of patients with advanced renal cell carcinoma (aRCC) treated with immuno-oncology combinations are important for clinicians and patients. Here, we describe treatment patterns, adverse events (AEs), and outcomes of patients with aRCC treated with first-line (1L) nivolumab plus ipilimumab (NIVO+IPI) or pembrolizumab plus axitinib (PEM+AXI).</div></div><div><h3>Methods</h3><div>This retrospective medical chart review included patients with aRCC who initiated 1L NIVO+IPI between May-2018 and May-2021 or PEM+AXI between May-2019 and May-2021. Inverse probability of treatment weighting was performed, providing balanced baseline characteristics. Physician-reported response (RW objective response rate [rwORR], duration of response [rwDOR]) and immune-related AEs are described. RW progression-free survival (rwPFS) and overall survival (rwOS) were estimated using Kaplan-Meier analysis.</div></div><div><h3>Results</h3><div>225 patients were treated with 1L NIVO+IPI and 130 with 1L PEM+AXI. The median duration of 1L therapy was 15.0 months for NIVO+IPI and 14.5 months for PEM+AXI. After weighting, each cohort was ∼60% male, ∼65 years old, and ∼90% had intermediate/poor risk scores at initiation. The median follow-up post-1L initiation was 22.4 months for NIVO+IPI and 19.0 months for PEM+AXI (<em>P</em> = .006). The rwORR was comparable between cohorts (NIVO+IPI, 71.5%; PEM+AXI, 77.3%; <em>P</em> = .24), whereas the median rwDOR was significantly longer in the NIVO+IPI versus the PEM+AXI cohort (11.0 vs. 8.0 months; <em>P</em> < .0001). While median rwPFS and rwOS did not differ by treatment (<em>P</em> = .20 and 0.37, respectively), estimates for rwPFS and rwOS probability at 24 months post-1L initiation for treatment were nonsignificantly higher for NIVO+IPI versus PEM+AXI (rwPFS: 0.29 vs. 0.18, respectively; rwOS: 0.63 vs. 0.57, respectively). The overall rate of immune-related AEs was similar between cohorts (NIVO+IPI, 29.1%; PEM+AXI, 25.3%; significance not tested).</div></div><div><h3>Conclusions</h3><div>Overall results from this RW study were similar for patients with aRCC who received 1L NIVO+IPI or PEM+AXI, although nonsignificant results suggest rwPFS and rwOS at later timepoints may be improved for patients who receive 1L NIVO+IPI versus PEM+AXI. Additional research with larger samples and extended follow-up is necessary to understand potential long-term differences in clinical outcomes.</div></div>","PeriodicalId":10380,"journal":{"name":"Clinical genitourinary cancer","volume":"23 6","pages":"Article 102443"},"PeriodicalIF":2.7,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145411087","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Anna Amela Valsecchi , Maria Concetta Cursano , Francesco Pantano , Ugo De Giorgi , Giuseppe Procopio , Daniele Santini , Massimo Di Maio , Meet-URO group
{"title":"Bone Health and Body Composition as Predictive and Prognostic Markers in Metastatic Castration-resistant Prostate Cancer: A Meet-URO Narrative Review","authors":"Anna Amela Valsecchi , Maria Concetta Cursano , Francesco Pantano , Ugo De Giorgi , Giuseppe Procopio , Daniele Santini , Massimo Di Maio , Meet-URO group","doi":"10.1016/j.clgc.2025.102433","DOIUrl":"10.1016/j.clgc.2025.102433","url":null,"abstract":"<div><div>Metastatic castration-resistant prostate cancer (mCRPC) presents several challenges, including identifying predictive and prognostic markers for available therapies in order to guide the best clinical choice. Alongside well-known markers such as prostate specific antigen, researchers are trying to understand the role of bone health assessment and body composition in this context. Bone turnover markers, measurable in blood or urine, provide insights into bone formation and resorption dynamics, while body composition metrics derived from radiological imaging (e.g., CT or MRI) can quantify muscle mass, fat distribution, and obesity-related parameters.</div><div>This narrative review examines current evidence on the relationship between bone health, body composition, and clinical outcomes in mCRPC. We synthesize findings from recent studies evaluating their association with treatment response, adverse event profiles, and survival, highlighting potential mechanisms linking skeletal and metabolic status with disease progression.</div><div>Although preliminary data suggest that selected bone and body composition markers may inform risk stratification and therapeutic decision-making, evidence remains heterogeneous and largely derived from retrospective or small prospective cohorts. Standardization of measurement methods and thresholds is lacking, limiting their immediate clinical application.</div><div>Future prospective trials incorporating these parameters as secondary endpoints are warranted to clarify their independent prognostic value and predictive utility. A better understanding of these markers could support more personalized treatment strategies, improve monitoring of therapy-related toxicities, and ultimately enhance both survival and quality of life in patients with mCRPC.</div></div>","PeriodicalId":10380,"journal":{"name":"Clinical genitourinary cancer","volume":"23 6","pages":"Article 102433"},"PeriodicalIF":2.7,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145263068","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Avani P. Desai , Gianpaolo Carpinito , Amir Feinberg , Marvin A. Meza Jarquín , Isaiah Zipple , Deborah Usinger , Shannon Myers , Ram Sankar Basak , Eric Wallen , Marc A. Bjurlin , Mathew Raynor , Matthew E. Nielsen , Hung-Jui Tan
{"title":"Data Sources for Clinical T1 Renal Masses and the Potential for Bias","authors":"Avani P. Desai , Gianpaolo Carpinito , Amir Feinberg , Marvin A. Meza Jarquín , Isaiah Zipple , Deborah Usinger , Shannon Myers , Ram Sankar Basak , Eric Wallen , Marc A. Bjurlin , Mathew Raynor , Matthew E. Nielsen , Hung-Jui Tan","doi":"10.1016/j.clgc.2025.102435","DOIUrl":"10.1016/j.clgc.2025.102435","url":null,"abstract":"<div><h3>Introduction</h3><div>The rising incidence of early-stage kidney cancer has driven comparative effectiveness research using cancer registry and administrative data. These sources may be biased for small renal masses (SRM), where histologic confirmation prior to treatment is not standard. To better understand these limitations, we compared characteristics of patient populations across three SRM data sources.</div></div><div><h3>Patients and Methods</h3><div>We identified patients diagnosed with clinical T1 renal masses from 2019 to 2020 at our institution. Data were obtained from the institutional cancer registry, a prospective clinical trial, and electronic health record (EHR) extraction. Demographic and clinical characteristics were compared across cohorts using chi-squared, Fisher’s exact testing, and multivariable regression analysis. Radiologic reports were reviewed for terminology concordance with registry inclusion criteria.</div></div><div><h3>Results</h3><div>Among 555 cases, 169 (30.5%) were in the clinical trial, 273 (49.2%) in the cancer registry only, and 113 (20.4%) from EHR extraction only. Active surveillance was more common in the EHR extraction cohort (85%) than in the registry (48%) or trial (33%) (<em>P</em> < .001). The registry and trial cohorts had higher Charlson Comorbidity Index scores (<em>P</em> < .001), and the clinical trial cohort included fewer Hispanic/Latino patients (<em>P</em> = .04) and non-English speakers (<em>P</em> < .01). Registry capture was limited by terminology in radiologic reports, with qualifying terms present in only 15% of EHR cases and 49% of delayed registry entries.</div></div><div><h3>Conclusions</h3><div>Cohort composition differed by data source, particularly for patients undergoing active surveillance. Clinicians must recognize potential bias when interpreting findings. Standardized radiologic reporting and revised registry criteria may ensure more complete data for early-stage kidney cancer.</div></div>","PeriodicalId":10380,"journal":{"name":"Clinical genitourinary cancer","volume":"23 6","pages":"Article 102435"},"PeriodicalIF":2.7,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145263069","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}